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L 126/34 EN Official Journal of the European Union 22.5.

2003

COMMISSION DIRECTIVE 2003/40/EC


of 16 May 2003
establishing the list, concentration limits and labelling requirements for the constituents of natural
mineral waters and the conditions for using ozone-enriched air for the treatment of natural
mineral waters and spring waters

THE COMMISSION OF THE EUROPEAN COMMUNITIES, most sensitive to the risk of fluorosis, where the fluoride
content of a natural mineral water exceeds this guide
Having regard to the Treaty establishing the European value, a reference to this fact, which can be seen easily
Community, by the consumer, also needs to be made on the label.
Having regard to Council Directive 80/777/EEC (1), of 15 July
1980 on the approximation of the laws of the Member States
relating to the exploitation and marketing of natural mineral (7) The Scientific Committee for Food indicated a guide
waters, as last amended by Directive 96/70/EC of the European value for boron in natural mineral waters based on the
Parliament and of the Council (2), and in particular Article WHO (5), recommendations of 1996. However, the
11(1) thereof, WHO and other internationally recognised scientific
organisations have since then made new appraisals of
Whereas: boron's effect on public health and have recommended
higher values. The European Food Safety Authority
(1) Constituents may be present in the natural state in should therefore be consulted about boron in natural
certain natural mineral waters because of their hydrogeo- mineral waters so that the new scientific appraisals avail-
logical origin and may present a risk to public health able can be taken into account and a maximum limit for
above a certain concentration. It is therefore deemed boron should not be set at this stage.
necessary to establish concentration limits for these
constituents in natural mineral waters.
(8) The Scientific Committee for Food also indicated in the
(2) Article 11 of Directive 80/777/EEC makes provision for above opinion the acceptable level for barium, manga-
adopting harmonised concentration limits for the consti- nese and arsenic in natural mineral waters. For the other
tuents of natural mineral waters after consulting the undesirable constituents of natural mineral waters which
Scientific Committee for Food, and for labelling require- may have a harmful effect on public health, the revised
ments to indicate, where applicable, the presence of Codex standard lays down maximum limits that afford
certain constituents at high concentrations. sufficient protection for public health. However, the
limit for nitrates is deemed to be too low in the light of
(3) The Scientific Committee for Food issued an opinion (3), the available data and should be brought into line with
on arsenic, barium, fluoride, boron and manganese and, that for drinking water (6).
for other constituents of natural mineral waters, vali-
dated the limits recommended by the WHO for drinking
water.
(9) The maximum limit for nitrates laid down in the Codex
(4) The revised Codex standard for ‘natural mineral standard affords sufficient protection for public health
waters’ (4), gives, for health purposes, a list of constitu- and should serve as a reference for Community and
ents and maximum limits for these constituents. It was international trade in natural mineral waters. However,
adopted on the basis of the most recent international during the procedure for official recognition of natural
scientific data and affords sufficient public health protec- mineral water sources referred to in Article 1 of the
tion. aforementioned Directive, the Member States' competent
authorities must be able to take a lower guide value for
(5) It is generally acknowledged that a low-level fluoride nitrates in natural mineral waters collected within their
intake can have a beneficial effect on teeth. By contrast, territory.
excessive fluoride intake across the board can have
harmful effects on public health. Thus, it is necessary to
lay down a harmonised maximum limit for fluoride in (10) Natural mineral waters whose content in certain consti-
natural mineral waters affording sufficient protection for tuents exceeds the maximum limits for these constitu-
the population as a whole. ents shall, for public health purposes, be subjected to the
separation treatments for these constituents. In order to
(6) The World Health Organisation recommended a guide
enable the operators concerned to make the necessary
value of 1,5 mg/l for fluoride for drinking water, which
investment to comply with these new standards, suffi-
was validated for natural mineral waters by the Scientific
cient periods should be allowed before the maximum
Committee for Food in the abovementioned opinion. In
concentration limits for such constituents come into
order to protect infants and young children, who are the
force, in particular with regard to fluoride and nickel for
which no separation treatment has yet been assessed or
(1) OJ L 229, 30.8.1980, p. 1. authorised at Community level.
(2) OJ L 299, 23.11.1996, p. 26.
(3) Opinion of 13 December 1996 on arsenic, barium, fluoride, boron
and manganese in natural mineral waters. (5) WHO (1996): guidelines on the quality of drinking water, second
(4) Codex standard 108-1981, Rev 1-1997, revised during the 7th edition, volume 2.
session of the CCNMW (October 2000). (6) Council Directive 98/83/EC (OJ L 330 of 5.12.1998, p. 32).
22.5.2003 EN Official Journal of the European Union L 126/35

(11) For the purposes of official checks on these constituents, It also defines the conditions for using ozone-enriched air for
a fluctuation margin around the maximum concentra- separating compounds of iron, manganese, sulphur and arsenic
tion limits is required corresponding to measurement from natural mineral waters or spring waters, and the labelling
uncertainties. requirements for waters which have undergone such treatment.

(12) Article 4(1)(b) of Directive 80/777/EEC (as amended)


provides for the separation of iron, manganese, sulphur
and arsenic from certain natural mineral waters, using Article 2
ozone-enriched air treatment, subject to an assessment
of this treatment by the Scientific Committee for Food 1. By 1 January 2006 at the latest, natural mineral waters
and adoption of the conditions for use of this treatment shall, at the time of packaging, comply with the maximum
by the Standing Committee on the Food Chain and concentration limits set out in Annex I for the constituents
Animal Health. listed in that Annex.

(13) The Scientific Committee for Food issued an opinion (1), 2. However, in the case of fluorides and nickel, the deadline
on this treatment which provides for both given referred to above is extended until 1 January 2008.
methods and results. However, it is deemed appropriate
to stipulate only given results, in order to take account
of developments in ozone-enriched air treatment techni- 3. By way of derogation from paragraph 1, during the
ques and treatment variability depending on the procedure for official recognition of natural mineral waters
physico-chemical composition of the water to be treated. collected within their territory, the competent authorities of the
Member States may take a lower reference value for nitrates
and nitrites, provided that the same reference value is applied
(14) Moreover, treatment with ozone-enriched air should not to all applications made to them.
modify the composition in terms of characteristic consti-
tuents within the meaning of Article 7(2)(a) of Directive
80/777/EEC, or have a disinfectant action within the
meaning of Article 4(3) or generate the formation of
Article 3
treatment residues which may have a harmful effect on
public health.
For the purposes of official controls, the Member States shall
(15) Pursuant to Article 7(2)(c) of the above Directive, natural comply with the specifications listed in Annex II for analysing
mineral waters treated with ozone-enriched air must the constituents listed in Annex I.
bear a reference on the label giving customers sufficient
information about the treatment carried out.
Article 4
(16) In accordance with the provisions of Article 9(4)(a)
fourth indent of Directive 80/777/EEC, the provisions
concerning the treatments provided for in Article 4 of 1. Natural mineral waters with a fluoride concentration
the Directive, and in particular treatment with ozone- exceeding 1,5 mg/l shall bear on the label the words ‘contains
enriched air, are applicable to spring waters. more than 1,5 mg/l of fluoride: not suitable for regular
consumption by infants and children under 7 years of age’.
(17) The measures laid down in this Directive are in accor-
dance with the opinion of the Scientific Committee on 2. The label information laid down in paragraph 1 of this
the Food Chain and Animal Health, Article shall be placed in immediate proximity to the trade
name and in clearly visible characters.

3. Natural mineral waters which, under the terms of para-


graph 1 of this Article, bear label information, shall indicate
HAS ADOPTED THIS DIRECTIVE: the actual fluoride content in relation to the physico-chemical
composition in terms of essential constituents, as laid down in
Article 7(2)(a) of Directive 80/777/EEC.
Article 1

This Directive establishes the list of constituents of natural Article 5


mineral waters which may present a risk to public health, the
limits for admissible levels of these constituents, the deadlines
for application of these limits and the labelling requirements 1. Without prejudice to the provisions of Article 4(1)(b) of
for certain constituents. These constituents must be present in Directive 80/777/EEC, application of the treatment of natural
the water naturally and may not result from contamination at mineral waters with ozone-enriched air must be notified in
source. advance to the competent authorities, who shall ensure that:

(1) Opinion of the Scientific Committee for Food of 7 June 1996 on (a) use of such treatment is justified by the composition of the
the use of ozone for separating unstable elements such as iron, water in terms of compounds of iron, manganese, sulphur
manganese and arsenic from natural mineral waters. and arsenic;
L 126/36 EN Official Journal of the European Union 22.5.2003

(b) the operator takes all measures necessary to guarantee that 2. Without prejudice to the deadlines set out in Article 2(1)
the treatment is effective and safe and to allow it to be and (2), the Member States shall prohibit the marketing of
checked by the competent authorities. products not complying with the present Directive from 1 July
2004. However, products packaged and labelled prior to 1 July
2. Ozone-enriched air treatment of natural mineral waters 2004 may be sold until stocks are exhausted.
must comply with all the following conditions:
(a) the physico-chemical composition of the natural mineral
Article 9
waters in terms of essential constituents shall not be modi-
fied by the treatment; The Member States shall bring into force the laws, regulations
(b) the natural mineral water before treatment must comply and administrative provisions necessary to comply with this
with the microbiological criteria laid down in Article 5(1) Directive by 31 December 2003 at the latest. They shall forth-
and (2) of Directive 80/777/EEC; with inform the Commission thereof.
(c) the treatment shall not lead to the formation of residues The provisions adopted pursuant to this paragraph shall
with a concentration exceeding the maximum limits laid contain a reference to this Directive or shall be accompanied
down in Annex III or residues which could pose a risk to by such reference at the time of their official publication.
public health. Member States shall determine how such reference is to be
made.
Article 6
Pursuant to Article 7(2)(c) of Directive 80/777/EEC, the label- Article 10
ling of natural mineral waters which have been treated with
This Directive shall enter into force on the 20th day following
ozone-enriched air shall bear, in proximity to the analytical
composition of characteristic constituents, the words ‘water that of its publication in the Official Journal of the European
subjected to an authorised ozone-enriched air oxidation tech- Union.
nique’.
Article 11
Article 7
This Directive is addressed to the Member States.
Without prejudice to the provisions of Article 9(4)(b) of Direc-
tive 80/777/EEC, the provisions of Articles 5 and 6 of this
Directive shall apply to spring waters.
Done at Brussels, 16 May 2003.
Article 8
For the Commission
1. The Member States shall take the necessary measures to
permit the marketing of products complying with the present David BYRNE
Directive by 1 January 2004 at the latest. Member of the Commission
22.5.2003 EN Official Journal of the European Union L 126/37

ANNEX I

Constituents naturally present in natural mineral waters and maximum limits which, if exceeded, may pose a
risk to public health

Maximum limits
Constituents
(mg/l)

Antimony 0,0050

Arsenic 0,010 (as total)

Barium 1,0

Boron For the record (*)

Cadmium 0,003

Chromium 0,050

Copper 1,0

Cyanide 0,070

Fluorides 5,0

Lead 0,010

Manganese 0,50

Mercury 0,0010

Nickel 0,020

Nitrates 50

Nitrites 0,1

Selenium 0,010

(*) The maximum limit for boron will be fixed, where necessary, following an
opinion of the European Food Safety Authority and on a proposal from the
Commission by 1 January 2006.
L 126/38 EN Official Journal of the European Union 22.5.2003

ANNEX II

Performance characteristics (*) for analysing the constituents in Annex I

Accuracy of para- Precision of para- Detection limit in % of


Constituents metric value in % metric value parametric value Notes
(Note 1) (Note 2) (Note 3)

Antimony 25 25 25

Arsenic 10 10 10

Barium 25 25 25

Boron See Annex I

Cadmium 10 10 10

Chromium 10 10 10

Copper 10 10 10

Cyanides 10 10 10 Note 4

Fluorides 10 10 10

Lead 10 10 10

Manganese 10 10 10

Mercury 20 10 20

Nickel 10 10 10

Nitrates 10 10 10

Nitrites 10 10 10

Selenium 10 10 10

(*) Analytical methods for measuring concentrations of the constituents listed in Annex I must be able to measure, as a minimum,
concentrations equal to the parametric value with a specified accuracy, precision and detection limit. Whatever the sensitivity of the
method of analysis used, the result will be expressed using at least the same number of decimal places as for the maximum limit laid
down in Annex I.
Note 1: accuracy is the systematic error and is the difference between the average value of a large number of repeated measurements
and the exact value.
Note 2: precision is the random error and is expressed in general as the standard deviation (within a batch and between batches) of a
sample of results from the average. Acceptable precision is equal to twice the relative standard deviation.
Note 3: the detection limit is:
— either three times the relative standard deviation within a batch of a natural sample containing a low concentration of
the parameter,
— or five times the relative standard deviation within a batch of a virgin sample.
Note 4: the method should make it possible to determine total cyanide in all its forms.
22.5.2003 EN Official Journal of the European Union L 126/39

ANNEX III

Maximum limits for residues from treatment of natural mineral waters and spring waters by ozone-enriched
air

Maximum limit (*)


Treatment residue
(µg/l)

Dissolved ozone 50

Bromates 3

Bromoforms 1

(*) Compliance with the maximum limits is monitored by the competent authori-
ties in the Member States at the time of bottling or other form of packaging
intended for the final consumer.